CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA

K982269 · Allegiance Healthcare Corp. · MIA · Jul 23, 1998 · Anesthesiology

Device Facts

• Record ID: K982269
• Device Name: CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
• Applicant: Allegiance Healthcare Corp.
• Product Code: MIA · Anesthesiology
• Decision Date: Jul 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Clear Hub Spinal Needle is a device used in various clinical procedures, including but not limited to, lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management) and amniocentesis. The primary intended use of the Clear Hub Spinal Needle is to accommodate the procedural aspiration and /or administration of diagnostic and therapeutic fluids.

Device Story

Clear Hub Spinal Needle consists of stainless steel cannula attached to blue-tinted transparent polycarbonate or acrylic hub; hub features wings and finger holds for grip and stability. Device used by clinicians in clinical settings for lumbar puncture, myelogram, spinal anesthesia, nerve block, and amniocentesis. Facilitates aspiration or administration of diagnostic and therapeutic fluids. Provides visual confirmation of fluid flow through transparent hub.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including cytotoxicity, sensitization, irritation/intracutaneous reactivity, and systemic toxicity (acute). Materials met all testing requirements.

Technological Characteristics

Stainless steel cannula; polycarbonate or acrylic hub. Blue-tinted transparent hub design. Manual operation. Non-powered. Sterile.

Indications for Use

Indicated for patients requiring aspiration and/or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedures, specifically lumbar puncture, myelogram, and amniocentesis.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• Baxter Pharmaseal Clear Hub Spinal Needle

Submission Summary (Full Text)

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## JUL 23 1998

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K982269

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rk, Illinois 60085-6787

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XII. CLEAR HUB SPINAL NEEDLE

Manufacturer:

Allegiance Healthcare Corporation 400 East Foster Road Mannford, OK 74044

Allegiance Healthcare Corporation 1500 Waukegan Road MP-WM

Pharmaseal Clear Hub Spinal Needle

for proper control, stability and grip.

owned by Baxter Healthcare Corporation

polycarbonate or acrylic hub, connected to the stainless steel cannula and hub assembly. The

The Clear Hub Spinal Needle is a blue tinted transparent

cannula/hub assembly provides wings and finger holds

Regulatory Affairs Contact:

Telephone:

[phone]

McGaw Park, IL 60085

Zarina Bilgrami

June, 1998 Date Summary Prepared:

Spinal Needle Common Name:

Class II per 21CFR § 868.5150, Spinal, Short term Classification: Needle

Predicate Device:

Description:

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CLEAR HUB SPINAL NEEDLE

Intended Use:

The Clear Hub Spinal Needle is a device used in various clinical procedures, including but not limited to, lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management) and amniocentesis. The primary intended use of the Clear Hub Spinal Needle is to accommodate the procedural aspiration and /or administration of diagnostic and therapeutic fluids.

Substantial Equivalence:

The proposed Allegiance Clear Hub Spinal Needle is substantially equivalent to the currently marketed Baxter Pharmaseal Clear Hub Spinal Needle in that:

- intended use is the same
- performance attributes are the same

Summary of testing: All materials used in the fabrication of this Clear Hub Spinal Needle device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation/ intracutaneous reactivity and systemic toxicity (acute) as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 23 1998

Ms. Zarina Bilgrami Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787

Re: K982269 Clear Hub Spinal Needle Regulatory Class: II (two) Product Code: 73 MIA Dated: June 26, 1998 Received: June 29, 1998

Dear Ms. Bilgrami:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Zarina Bilgrami

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: [phone]

## Indications for Use

510(k) Number (if known):

Not Known

Device Name:

Clear Hub Spinal Needle

Indications For Use:

The Clear Hub Spinal Needle is a device which is intended for patients requiring aspiration and or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedure, specifically lumbar puncture, myelogram and amniocentesis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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